Skip to content
Triangle logo TriangleGet started
← Study library

NCT00601718 · REGISTRY CONDITION SEARCH

Vorinostat, Rituximab, Ifosfamide, Carboplatin, and Etoposide in Treating Patients With Relapsed or Refractory Lymphoma or Previously Untreated T-Cell Non-Hodgkin Lymphoma or Mantle Cell Lymphoma

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
COMPLETED
Registry last update
2017-05-25

This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Maximum Tolerated Dose of Vorinostat

→

outcome · POSTED

Safety and Toxicity According to CTCAE v3.0

→

outcome · POSTED

Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy

→

outcome · POSTED

Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility Criteria
Inclusion Criteria: * Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkins disease), or untreated T-NHL or MCL * Patients with other lymphomas that have not received any prior therapy and are not candidates for anthracycline-based therapies, are eligible with PI review and approval * Revised European American classification (REAL), or World Health Organization (WHO) classification of patient's malignancies must be provided * Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters \>= 2 cm * Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy * Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck * Patients should not have evidence of active central nervous system lymphoma * Electrocardiogram (EKG) must be free of any arrhythmias (excluding sinus arrhythmia or infrequent premature ventricular contractions) * Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2 * Absolute neutrophil count (ANC) \>= 1,500/mm\^3 * Serum creatinine \< 1.5 mg/dl or creatinine clearance greater than 60/ ml per minute by the following formula (all tests must be performed within 28 days prior to registration) * Total bilirubin \< 1.5 times upper limit of normal, aspartate aminotransferase (AST) \< 5 times upper limit of normal * Patients must have a serum lactate dehydrogenase (LDH) performed within 14 days prior to registration * All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines * Patients must be anticipated to complete at least 2 cycles of chemotherapy * Platelets \>= 100,000/mm\^3 (without transfusion) Exclusion Criteria: * Patients known to be human immunodeficiency virus (HIV) positive * Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method * Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease free for 5 years or greater, unless approved by the protocol Chair or Co-Chair * Patients that are refractory (i.e. not responded or progressed within 6 months) to a carboplatin, cisplatin, ifosfamide, or etoposide-based regimen-based regimen * Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy (including active infection, uncontrolled hypertension, congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months, or uncontrolled arrhythmia) * Patients with a history of impaired cardiac status (including history of severe coronary artery disease, cardiomyopathy, congestive heart failure or arrhythmia); if the patient's history is questionable, a measurement of left ventricular ejection fraction should be obtained within 42 days prior to registration; patients with left ventricular ejection fraction \< 50% are not eligible * Autologous or allogeneic transplantation within 12 months or radioimmunotherapy within 6 months of registration * No concurrent treatment with valproic acid or on valproic acid within 2 weeks of study enrollment * No prior treatment with histone deacetylase inhibitors * No concurrent therapy for this malignancy
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients receive vorinostat PO QD on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
    intervention Names
    1. Drug: vorinostat
    2. Biological: rituximab
    3. Drug: ifosfamide
    4. Drug: carboplatin
    5. Drug: etoposide
    6. Other: pharmacological study
    7. Other: laboratory biomarker analysis
    8. Genetic: gene expression analysis
    label
    Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Given PO
    name
    vorinostat
    other Names
    1. L-001079038
    2. SAHA
    3. suberoylanilide hydroxamic acid
    4. Zolinza
    type
    DRUG
  2. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Given IV
    name
    rituximab
    other Names
    1. IDEC-C2B8
    2. IDEC-C2B8 monoclonal antibody
    3. Mabthera
    4. MOAB IDEC-C2B8
    5. Rituxan
    type
    BIOLOGICAL
  3. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Given IV
    name
    ifosfamide
    other Names
    1. Cyfos
    2. Holoxan
    3. IFF
    4. IFX
    5. IPP
    type
    DRUG
  4. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Given IV
    name
    carboplatin
    other Names
    1. Carboplat
    2. CBDCA
    3. JM-8
    4. Paraplat
    5. Paraplatin
    type
    DRUG
  5. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Given IV
    name
    etoposide
    other Names
    1. EPEG
    2. VP-16
    3. VP-16-213
    type
    DRUG
  6. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Correlative studies
    name
    pharmacological study
    other Names
    1. pharmacological studies
    type
    OTHER
  7. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Correlative studies
    name
    laboratory biomarker analysis
    type
    OTHER
  8. arm Group Labels
    1. Treatment (enzyme inhibitor, monoclonal antibody, chemotherapy
    description
    Correlative studies
    name
    gene expression analysis
    type
    GENETIC
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
29
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    Maximum Tolerated Dose of Vorinostat
    time Frame
    28 days post last dose of study drug
  2. description
    Common dose limiting toxicities.
    measure
    Safety and Toxicity According to CTCAE v3.0
    time Frame
    3-5 weeks post end of treatment
  3. measure
    Efficacy (Response Rate) of Vorinostat Combined With RICE Chemotherapy
    time Frame
    3-5 weeks post end of treatment
  4. measure
    Ability to Proceed to Peripheral Blood Stem Cell Collection Following Treatment
    time Frame
    1-3 weeks post end of treatment
Full study description
brief Summary
This phase I/II trial is studying the side effects and best dose of vorinostat when given together with rituximab, ifosfamide, carboplatin, and etoposide and to see how well they work in treating patients with relapsed or refractory lymphoma or previously untreated T-cell non-Hodgkin lymphoma or mantle cell lymphoma. Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with rituximab and combination chemotherapy may kill more cancer cells
detailed Description
OBJECTIVES: I. To determine maximally tolerated dose of vorinostat that can be combined with RICE chemotherapy in patients with relapsed lymphoid malignancies. II. To determine the safety and toxicity of the above regimen. III. To gain a preliminary assessment of the efficacy of the above regimen. IV. To determine the ability to proceed to peripheral blood stem cell collection following the above regimens (the impact of above regimen on stem cell reserve). V. To describe vorinostat concentration attained at or near the MTD. VI. To evaluate the change of histone acetylation patterns and pro-apoptotic proteins of primary target (tumor) and non-target peripheral blood mononuclear cells (PBMC) cells following high-dose HDAC inhibition. VII. To describe the gene expression profile changes of tumor and non-tumor cells following high-dose HDAC inhibition. OUTLINE: This is a phase I/II dose-escalation study of vorinostat. Patients receive vorinostat orally (PO) once daily (QD) on days 1-5, ifosfamide IV continuously over 24 hours and carboplatin IV over 1 hour on day 4, and etoposide IV over 1 hour on days 3-5. Patients who are CD20+ also receive rituximab IV once on day 3, 4, or 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 4 years.
Source references
references
  1. citation
    Budde LE, Zhang MM, Shustov AR, Pagel JM, Gooley TA, Oliveira GR, Chen TL, Knudsen NL, Roden JE, Kammerer BE, Frayo SL, Warr TA, Boyd TE, Press OW, Gopal AK. A phase I study of pulse high-dose vorinostat (V) plus rituximab (R), ifosphamide, carboplatin, and etoposide (ICE) in patients with relapsed lymphoma. Br J Haematol. 2013 Apr;161(2):183-91. doi: 10.1111/bjh.12230. Epub 2013 Jan 29.
    pmid
    23356514
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-5cf7e239d9968de829c6
      requested nct id
      NCT00601718
      primary nct id
      NCT00601718
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      payload sha256
      2ce2436cc24f1b9a97e4b460b81e005a7ce905094d96f2bb4ea4c491981a6bef
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-5cf7e239d9968de829c6
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT00601718
      occurrences
      1. context exact
        NCT00601718
        end
        11
        exact text
        NCT00601718
        start
        0
      offset unit
      unicode_code_points
      query cond
      Plasma Cell Neoplasms
      query disease state id
      ds-plasma-cell-neoplasms
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-plasma-cell-neoplasms-000.json
      source file sha256
      2314ce01316b2d7044d298c6d25eda12e99cc5f44273bc75efed6cd5e03a8c14
      source json pointer
      /studies/157/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      d197b83ba0fa20514ee4594390e2346a709c8e7886b91ae073db9a7d2bb65ee9

    Preserved source evidence · Not medical advice